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Medical Device Prototype Stent from China

Drug-eluting coronary stent prototype with experimental polymer coating for benchtop and animal model testing. Imported by medical device company for regulatory submission fatigue testing. 9813.00.30 for experimental medical device development.

Duty Rate — China → United States

12.5%

Rate breakdown

9903.05.3112.5%Section 301 (forced labor) — additional 12.5% ad valorem on products of China

Import Tips

FDA IDE number and test protocol mandatory for clearance

Include animal study approvals and destruction plans

Small quantities only - production lots trigger Chapter 90 classification